Research Compliance Newsletter - November 2022 Edition
What a year of unexpected events – again! It has been a year of challenges, staff changes, learnings, achievements and many wins. This is our final newsletter before Christmas, so even though it may seem a little early for Christmas wishes, we do wish you all a relaxing, safe and happy Christmas with your loved ones. Please read on to see a few of our highlights, updates and hot tips.
Team update
We welcome Jodie back from leave, commencing in her new role of Research Monitoring Officer. Welcome back, Jodie!
We welcome Sophie, our new Agreements Officer. Welcome Sophie!
Christmas period advisory notices
The HREC Office will be unattended from Thursday 22 December 2022 to Monday 9 January 2023.
The Research Governance Office will be closed from Monday 26 December 2022, reopening Tuesday 3 January 2023.
For urgent queries of the Ethics or Research Governance offices over these periods, please contact Research Compliance Manager, Julie Cichero.
Please note: Submissions received by the Governance and Agreements offices after Monday 5 December 2022 may not be reviewed until after 3 January 2023. Please keep this in mind for your study timelines and booking of clinical trial activities.
Congratulations
We congratulate our Agreements Officer, Eloise, on her admission to the Supreme Court of Queensland as a lawyer. Congratulations, Eloise!
HREC Office update
We encourage researchers to contact the HREC Office before submitting a new Human Research Ethics Application. Templates for research project documents including Protocol, Participant Information and Consent Form and other useful templates can be accessed from our Mater Research webpage or by contacting us via email.
If you are planning to conduct a quality assurance, audit, or service evaluation project, please contact the HREC Office to discuss your project before submitting your application. A guide to help you define your project, work out whether your project is quality improvement or research and write the project plan is available from here on the Mater Research website. Please use the ‘Mater Quality Assurance and Exempt Research Form’ in ERM to submit your application for a Quality Assurance activity.
When submitting an amendment to an existing project in ERM, please remember to attach both track-changed and clean versions of updated documents.
Research Governance Office Update
Up until the end of October 2022, we have authorised 94 new SSAs and 387 amendments, and noted 364 progress/final reports and 396 safety/other reports. Review of these submissions has certainly kept us very busy, and it is great to see so much activity at Mater Research this year.
Please note that due to this heavy workload and recent staff shortages in the office, review of some new items may be delayed. During this time, review of new SSAs, amendments and important safety matters are being prioritised. We thank all our researchers for their patience and understanding.
Annual Safety Report
A new template has been developed and disseminated for annual safety reporting requirements to the TGA for studies where Mater is the Sponsor. Those research teams involved in Mater-sponsored TGA-registered trials are now required to complete this report annually when the Progress Report for the study is due. Details on how to submit have been included in the email that was sent to research teams who currently have TGA registered studies. Please contact RGO if you have any queries.
National SSA/National One Stop Shop consultation
We continue to be involved in the consultation process for the National One Stop Shop for health-related human research and the National SSA form. We look forward to receiving further information soon and sharing this with you as it evolves. Please see the Australian Commission on Safety and Quality in Health Care Website for more information on the National One Stop Shop and National SSA form.
Monitoring update
HREC Expiry and Progress Reports
We thank our researchers for their timely submissions of annual reports in response to the automatic reminder emails which are generated. It is great to see their dedication to working in line with regulatory requirements.
TGA GCP-Monitoring
The Therapeutic Goods Administration (TGA) has announced that from August 2022 they will start monitoring clinical trials in Australia for adherence to Good Clinical Practice (ICH-GCP) principles and guidelines. The TGA will take a risk-based approach to prioritising inspections. However, these inspections will occur randomly (i.e., randomly selected) or in response to significant safety concerns or identified non-compliance. Generally, 28 days’ notice will be given to the PI only prior to a monitoring inspection.
*Please take this as a reminder to stay up to date with GCP training and applying GCP principles to your research. Our preferred GCP training course is linked here. It is free, online and should take less than 60 minutes to complete.
Agreements update
DocuSign
The Agreements office is now transitioning all signature requirements into DocuSign. Please advise your external stakeholders to cease sending physical documents (unless specifically required). As we are centralising our signatures with an internal process, we will start to limit external electronic signature requests. We require that external parties provide a PDF of the contract to us.
If your contract requires an investigator to sign, we can assist with obtaining this signature in DocuSign.
A reminder to all teams to utilise your assigned ‘Research ID numbers’ (RIDXXXXX) provided to you by the office. By including your RID in your email, this assists the team to find your file quickly and resolve queries sooner. Additionally, please utilise existing email threads, to ensure all communications are centralised.
Biosafety and laboratory compliance update
Aubigny Place PC2 Laboratory update
The recent power network upgrades required significant activity in the labs and freezer rooms, with movement and consolidation of samples to other freezers, freezers placed on generator power and an all-round clean up. In addition, a loan -80 freezer has been installed, to provide sample storage space to cover the 2 freezers that are currently out of action. A HUGE thank you to all lab users and staff who chipped in to help with this work!
Imports, exports and domestic shipments of biological materials
If you are transporting biological materials in and out of the country or domestically, please contact our Laboratory and Safety Coordinator for a copy of the guidelines to ensure you are completing all required processes and documentation. There have been 2 recent cases of imported material being held by Customs due to insufficient or incorrect documentation.
A reminder that you must have a valid Import Permit to import biological materials. Mater Research holds an Import Permit that covers the import of standard biological material, delivered to the TRI.
UQ Animal Ethics Unit (AEU) update
The AEU has provided us with preferred correspondence pathways for highlighting urgency requirements and special considerations for submissions to the AEC. These have been shared with researchers by email. Suggestions have also been provided on how you can help to reduce the review timeframe, including having your application reviewed by at least one other person and ensuring the questions on the 3R’s and welfare are answered thoroughly. If you haven’t seen this email, please request a copy from laboratory.compliance@mater.uq.edu.au.
Be sure to check closing dates for submissions to all AECs, available here on the UQ website.
ERM update
A ‘Track Changes’ feature will soon be available on ERM forms. As an ERM user, you will be able to compare a previously submitted version of your form with the current version you are updating. A “Compare with Previous Submission” button will be available at the top-right of each page of the form. After this button is clicked, the system will save any changes on the page and compare them to the state of the form when it was submitted last. More details will be provided when this feature becomes available.
Updates have recently been made to several Mater Research forms in ERM. Please ensure your project is updated before creating a new form, to ensure you are using the latest version. Ensure all signed but unsubmitted forms are submitted before the project is updated, otherwise you will lose signatures already requested and collected!
ERM Hot Tips!
Expand a project within the Projects list, using the ‘>’ character located to the left of the Project title, to view all forms and their statuses. This is very useful to quickly spot any forms that haven’t been submitted and for project owners to confirm all forms have been submitted before updating a project.
Use the Folders to organise your projects. Projects can be moved from the Projects list into folders to tidy the work area. For example, you may decide to create a Closed folder that contains all projects that are now closed, or a separate folder for each therapeutic group you work with.
Remember, if you or your team members need training or assistance with ERM, please contact our ERM support person, Ruth Lee.